A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00781885
• Date of registration: 27/10/2008
• Prospective Registration: Yes
• Primary sponsor: Lung Biotechnology PBC
• Public title: A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients
• Scientific title: A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients
• Date of first enrolment: January 31, 2009
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00781885
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Ireland, United States

Contacts

• Name: Ted Staub, MS, MEng
• Affiliation: Study Sponsor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is male or female between the ages of 18 and 75 years of age, inclusive;

2. Has either idiopathic or familial PAH, PAH associated with collagen vascular disease,
or PAH induced by anorexigens;

3. Is clinically stable, as determined by the investigator;

4. Has previously undergone a cardiac catheterization which is consistent with PAH,
specifically PAPm =25 mmHg (at rest), PCWP (or left ventricular end diastolic
pressure) =15 mmHg, and PVR >3 wood units;

5. Has been on a course of an endothelin receptor antagonist (ERA) or phosphodiesterase
inhibitor (PDE-5) or the combination for at least 90 days at the time of the Baseline
visit;

6. Has an unencouraged six-minute walk distance (6MWD) between 300 and 600 meters at the
Screening visit;

7. Is able to communicate effectively with study personnel;

8. Is considered to be reliable, willing, cooperative and compliant with the study
protocol requirements;

9. Provides voluntary, written informed consent before participating in the study;

10. Is, if female, physiologically incapable of childbearing or is practicing an
acceptable method of birth control (i.e., surgical sterilization, approved hormonal
contraceptives, barrier methods [such as a condom or diaphragm] used with a
spermicide, or an intrauterine device).

Exclusion Criteria:

1. Has pulmonary venous hypertension, pulmonary veno-occlusive disease, pulmonary
capillary hemangiomatosis, severe chronic obstructive pulmonary disease, pulmonary
hypertension related to congenital heart disease, or chronic thromboembolic pulmonary
hypertension;

2. Is pregnant or lactating;

3. Has a known intolerance to beraprost sodium or prostanoids;

4. Has a pre-existing condition that could interfere with the absorption, distribution,
metabolism, or excretion of drugs;

5. Current use of tobacco products;

6. Known history of syncope;

7. Has, in the opinion of the Investigator, any concomitant disease other than those
accepted as part of the inclusion criteria that would compromise the patient or the
study;

8. Has had a change in or discontinued any PAH medication (with the exception of
anticoagulants) within 30 days prior to the Baseline visit;

9. Has received any prostanoid therapy within the 30 days prior to the Baseline visit or
be scheduled to receive additional prostanoid therapy during the study except for
acute vasodilatory testing;

10. Has received any investigational medication within 30 days prior to the Baseline visit
or be scheduled to receive another investigational drug during the course of this
study;

11. In the opinion of the investigator, may be unable to comply with the study protocol;

12. Has any preexisting disease known to cause pulmonary hypertension (e.g., obstructive
lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia,
mitral valve stenosis, portal hypertension) other than those listed in the inclusion
criteria;

13. Has donated blood or plasma or has lost a volume of blood >450 mL within six weeks
prior to the Baseline visit.

14. Has an ongoing hemorrhagic condition (e.g. upper digestive track hemorrhage,
hemoptysis, etc.) or has a pre-existing condition that, in the investigator's
judgement, may increase the risk for developing hemorrhage during the study (e.g.
hemophilia). However, transient hemorrhage (e.g. epistaxis, normal menstrual bleeding,
gingival bleeding, hemorrhoidal hemorrhage, etc.) would not preclude enrollment



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Beraprost sodium modified release

Primary Outcome(s)

Maximum Tolerated Dose (MTD) of BPS-MR in Pulmonary Arterial Hypertension (PAH) Patients, Following Chronic, Twice-daily Administration. [Time Frame: 10 Weeks]

Secondary Outcome(s)

Change in Body Mass Index (BMI) From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Apparent Volume of Distribution (Vz/F) of BPS-MR [Time Frame: pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 67]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Change in Weight From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Number of Participants That Reported at Least One Treatment-Emergent Adverse Event (TEAE) [Time Frame: 19 Weeks]

Apparent Clearance (CL/F) of BPS-MR [Time Frame: pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 67]

Change in Body Temperature From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Change in Respiratory Rate From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Change in Electrocardiogram Intervals From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Change in Heart Rate From Baseline to Week 19 [Time Frame: Baseline and 19 weeks]

Secondary ID(s)

BPS-MR-PAH-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00781885